VERTE-STACK® Spinal System

GUDID 00613994257789

SPACER X090612210 CAPS VS TTM 10 X 22MM

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis
Primary Device ID00613994257789
NIH Device Record Key5f4d62dd-020b-4ebe-a16b-073ade5f83f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERTE-STACK® Spinal System
Version Model NumberX090612210
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994257789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994257789]

Moist Heat or Steam Sterilization

[00613994257789]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-08-18

On-Brand Devices [VERTE-STACK® Spinal System]

00613994733733TRIAL X0909793 18X12
00613994729071CAP X0909779 CS PSR PK ANA 5X18X12
00613994729064CAP X0909780 CS PSR PK ANA 6X18X12
00613994729057CAP X0909781 CS PSR PK ANA 7X18X12
00613994729040CAP X0909782 CS PSR PK ANA 8X18X12
00613994729033CAP X0909783 CS PSR PK ANA 9X18X12
00613994729026CAP X0909784 CS PSR PK ANA 10X18X12
00613994729019STRUT X0909785 ANATOMIC PEEK 5X18X12
00613994729002CAP X0909786 ANATOMIC PEEK 5X20X12
00613994728999CAP X0909787 CS PSR PK ANA 12X20X6
00613994728982CAP X0909788 CS PSR PK ANA 12X20X7
00613994728975CAP X0909789 CS PSR PK ANA 12X20X8
00613994728968CAP X0909790 CS PSR PK ANA 12X20X9
00613994728951CAP X0909791 CS PSR PK ANA 12X20X10
00613994728944STRUT X0909792 ANATOMIC PEEK 5X20X12
00613994714442STRUT X1109041 CENTER PK 13X26
00613994714435STRUT X1109040 CENTER PK 11X26
00613994714428STRUT X1109039 CENTER PK 9X26
00613994714411STRUT X1109038 CENTER PK 14X22
00613994714404STRUT X1109037 CENTER PK 13X22
00613994714398STRUT X1109036 CENTER PK 12X22
00613994714381STRUT X1109035 CENTER PK 11X22
00613994714374STRUT X1109034 CENTER PK 10X22
00613994714367STRUT X1109033 CENTER PK 9X22
00613994714350STRUT X1109032 CENTER PK 8X22
00613994712721STRUT X1109002 TI CRESCENT 30X40
00613994692320STRUT X1009227 MED CNTR TI 0DEG 22MM
00613994692313STRUT X1009228 MED CNTR TI 0DEG 26MM
00613994692306STRUT X1009229 MED CNTR TI 0DEG 30MM
00613994692290STRUT X1009230 MED CNTR TI 0DEG 38MM
00613994692283STRUT X1009231 MED CNTR TI 0DEG 42MM
00613994692276STRUT X1009232 MED CNTR TI 0DEG 46MM
00613994692269STRUT X1009233 MED CNTR TI 0DEG 60MM
00613994692252STRUT X1009234 LRG CNTR TI 0DEG 22MM
00613994692245STRUT X1009235 LRG CNTR TI 0DEG 26MM
00613994692238STRUT X1009236 LRG CNTR TI 0DEG 30MM
00613994692221STRUT X1009237 LRG CNTR TI 0DEG 38MM
00613994692214STRUT X1009238 LRG CNTR TI 0DEG 42MM
00613994692207STRUT X1009239 LRG CNTR TI 0DEG 46MM
00613994692191STRUT X1009240 LRG CNTR TI 0DEG 60MM
00613994675538STRUT X0709161 8X22X3 DEG CENTER
00613994675521STRUT X0709162 10X22X3 DEG CENTER
00613994675514STRUT X0709163 12X22X3 DEG CENTER
00613994675507STRUT X0709164 8X22X6 DEG CENTER
00613994675491STRUT X0709165 10X22X6 DEG CENTER
00613994675484STRUT X0709166 12X22X6 DEG CENTER
00613994675477STRUT X0709167 8X22X9 DEG CENTER
00613994675460STRUT X0709168 10X22X9 DEG CENTER
00613994675453STRUT X0709169 12X22X9 DEG CENTER
00613994675446STRUT X0709170 8X26X3 DEG CENTER

Trademark Results [VERTE-STACK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERTE-STACK
VERTE-STACK
78100037 2774125 Dead/Cancelled
MEDTRONIC SOFAMOR DANEK INC.
2001-12-27
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